P25 Series Basic User Manual June 2019 PDF download

Statement SonoScape Medical Corp. (hereinafter called SonoScape) owns the intellectual property rights to this manual, and also maintains the contents of this manual as confidential information. This manual is a reference for the operation, maintenance and cleaning of this product and does not convey any license under the patent rights of SonoScape, nor the rights of others. This manual contains the information protected by copyrights or patents. Reproduction, amendment or translation of this manual in any manner whatsoever without the written permission of SonoScape is strictly prohibited. All information contained in this manual is believed to be correct. SonoScape shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this manual. SonoScape does not assume any liability arising out of any infringements of patents or other rights of third parties. This manual is based on the maximum configuration and therefore some contents may not apply to your product. This manual is subject to change without prior notice and legal obligation.

Manufacturer’s Responsibility SonoScape is responsible for the effects on safety, reliability and performance of this product, only if all the following requirements are met. ●● All installation operations, expansions, changes, modifications and repairs of this product are conducted by SonoScape authorized personnel. ●● ●●

The use or application of the product or the use of parts or accessories is approved by SonoScape.

●●

The product is used in accordance with the instructions for use.

The electrical installation of the relevant room complies with the applicable national and local requirements.

Documentation SonoScape provides the documentation consisting of various manuals: ●● The basic user manual describes the basic functions and operating procedures of the system. ●●

The advanced user manual provides information about the measurements and calculations available in each mode.

Understand the meanings of the following items clearly before reading this manual. Item

!

Meaning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in malfunction or damage of the system. Indicates a potentially biological hazardous situation which, if not avoided, may result in disease transmission. NOTE

Indicates precautions or recommendations that should be used in operating the system.

Boldfaced Word

Indicates controls on the control panel, or on-screen objects such as menu items or keys.

Item

Meaning

Click >

Move the cursor to the controls on the display and press the confirm button on the control panel. Select a menu item or a key following the path.

Contact Information Manufacturer: SonoScape Medical Corp. Address: Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District, Shenzhen, 518057, Guangdong, China Tel: +86-755-26722890 Fax: +86-755-26722850 E-mail: [email protected] Website: www.sonoscape.com

EU Representative: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg, Germany Tel: +49-40-2513175 Fax: +49-40-255726 E-mail: [email protected]

Contents 1 Safety�� 1 1.1

Intended Use�� 1

1.2

Safety Precautions�� 1 1.2.1 Electrical Safety�� 1 1.2.2 Mechanical Safety�� 2 1.2.3 Accessories Caring�� 3 1.2.4 Biohazard Considerations�� 3

1.3

Acoustic Power Principle�� 3 1.3.1 Biological Safety�� 4 1.3.2 ALARA�� 4 1.3.3 Mechanical and Thermal Indices�� 4 1.3.4 Transducer Surface Temperature Limits�� 5 1.3.5 Imaging Functions that Change Acoustic Output�� 5

1.4

Safety Symbols�� 5

2 System Overview�� 9 2.1

Standard System Configuration�� 9

2.2

Physical Specifications�� 9

2.3

System Components�� 10 2.3.1 Peripheral Device Panel��11 2.3.2 Power Supply Panel�� 12 2.3.3

Front Panel�� 12

2.3.4 Control Panel�� 13 2.3.5 Key Panel�� 16 2.3.6 Basic Screen�� 17 2.3.7 Touch Screen�� 17

3 Preparing the System�� 21 3.1

System Moving/Positioning�� 21

3.2

Connecting and Powering the System�� 21 3.2.1 Using the Mains Supply�� 21 3.2.2 Using the Battery�� 22 3.2.3 Indicators�� 23

3.3

Powering On/Off the System�� 23 3.3.1 Powering On the System�� 23 3.3.2 Powering Off the System�� 23 3.3.3 System Standby�� 23

3.4

Adjusting the System�� 24 3.4.1 Adjusting the Monitor Arm�� 24 3.4.2 Adjusting the Display Monitor�� 24 3.4.3 Adjusting the Control Panel�� 25

3.5

Connecting the Probe�� 26 3.5.1 Connecting the Probe�� 26 3.5.2 Connecting the Pencil Probe�� 26 3.5.3 Disconnecting the Probe�� 26

I

Contents 3.6

Connecting the Peripheral Device�� 26 3.6.1 Connecting the Foot switch�� 26 3.6.2 Connecting the Video Printer�� 27 3.6.3 Connecting the Network Printer�� 27 3.6.4 Connecting the USB Printer�� 28 3.6.5 Connecting the Coupling Gel Heater (Optional)�� 28

4 Customizing Your System�� 29 4.1

General System Settings�� 29 4.1.1 General Settings�� 29 4.1.2 Display Settings�� 31 4.1.3 Storage Settings�� 32 4.1.4 Defined-Key Settings�� 33 4.1.5 Biopsy Settings�� 35

4.2

Peripheral Device Settings�� 35

4.3

Defining Annotation Library�� 37

4.4

Body Mark Settings�� 38

4.5

Measurement Settings�� 38 4.5.1 General Measurement Settings�� 39 4.5.2 Application Settings�� 40 4.5.3 List Settings�� 43

4.6

Touch Screen Settings�� 44

4.7

Report Settings�� 45

4.8

Configuring DICOM�� 46 4.8.1 Store Settings�� 46 4.8.2 Commitment Store Settings�� 47 4.8.3 DICOM Worklist Settings�� 48 4.8.4 MPPS (Modality Performed Procedure Step) Settings�� 49 4.8.5 Print Service Settings�� 50 4.8.6 QR List�� 51

4.9

Defining System Defaults�� 52 4.9.1 Loading System Defaults�� 53 4.9.2 Creating System Defaults�� 53 4.9.3 Exporting or Importing System Defaults�� 53

4.10 User Security�� 54 4.10.1 User Settings�� 55 4.10.2 Administrator Settings�� 55 4.11 Viewing System Information�� 56 4.11.1 General Information�� 56 4.11.2 Acoustic Output�� 57

5 Preparing for an Exam�� 59 5.1

Acquiring Patient Information�� 59 5.1.1 Beginning a New Patient�� 59 5.1.2 Retrieving Archived Information�� 61 5.1.3 Using DICOM Worklist�� 62

5.2

Pausing/Resuming an Exam�� 62 5.2.1 Pausing an Exam�� 62 5.2.2 Resume an Exam�� 62

5.3

Completing/Discontinuing an Exam�� 62 II

Contents 5.3.1 Completing an Exam�� 62 5.3.2 Discontinuing an Exam�� 62

6 Acquiring Images�� 63 6.1

Selecting a Probe and an Exam Type�� 63 6.1.1 Customizing a Preset�� 63 6.1.2 Arranging the Presets Display�� 64

6.2

Acquiring B-Mode Images�� 65 6.2.1 Entering B Mode�� 65 6.2.2 Optimizing B-Mode Images�� 65

6.3

Acquiring Color Flow Images�� 70 6.3.1 CFM Mode�� 70 6.3.2 PDI Mode�� 70 6.3.3 TDI Mode�� 71 6.3.4 Optimizing CFM/PDI/TDI Mode Images�� 72

6.4

Acquiring M-Mode Images�� 75 6.4.1 M Mode�� 75 6.4.2 Anatomical M-Mode�� 76 6.4.3 Optimizing M-Mode Images�� 77

6.5

Acquiring Spectral Doppler Images�� 79 6.5.1 PW Mode�� 79 6.5.2 CW Mode�� 81 6.5.3 Optimizing Spectral Doppler Images�� 83

6.6

Acquiring Triplex-Mode Images�� 86 6.6.1 B+CFM/TDI +M�� 86 6.6.2 B+CFM/PDI/TDI +PW�� 87 6.6.3 B+CFM/PDI+CW�� 88

7 Elastography Imaging�� 89 7.1

Acquiring Elastography Images�� 89

7.2

Optimizing Elastography Images�� 90

7.3

Working with Elastography Images�� 92

8 Contrast Imaging�� 93 8.1

Entering Contrast Imaging�� 93

8.2

Optimizing Contrast Images�� 94

8.3

Acquiring Contrast Images�� 95

8.4

Working with Contrast Images�� 95

9 3D Imaging�� 97 9.1

Acquiring 3D Images�� 97

9.2

Working with 3D Images�� 99 9.2.1 Adjusting the ROI�� 99 9.2.2 Setting Display Format�� 100 9.2.3 Using Auto Face�� 100 9.2.4 Setting Render Mode�� 100 9.2.5 Cropping Reviews�� 101 9.2.6 Moving/Rotating/Magnifying Images�� 102 9.2.7 Optimizing 3D Image�� 103 9.2.8 Observing Reference Image by the Plane�� 103 9.2.9 Observing Reviews by the Slice�� 104 III

Contents 9.2.10 Setting the Scan Mode�� 105 9.2.11 Adjusting ZAngle/ZScale�� 105 9.2.12 Restoring the Image ��106 9.2.13 Customizing Presets ��106 9.2.14 Performing Follicle Auto-Measurement ��106

10 4D Imaging��107 10.1 Acquiring 4D Images�� 107 10.1.1 Entering the Real-Time 4D Imaging�� 107 10.1.2 Acquiring Dynamic 3D Image�� 109 10.2 Working with 4D Images�� 109

11 Working with Images�� 111 11.1 Imaging Features�� 111 11.1.1 Imaging Reverse�� 111 11.1.2 Split Screen Display�� 111 11.1.3 Auto�� 112 11.1.4 Harmonic Imaging�� 112 11.1.5 Panoramic Imaging�� 113 11.2 Magnifying an Image�� 115 11.2.1 Filling the Full Screen�� 115 11.2.2 Magnifying the Whole Image�� 115 11.2.3 Magnifying the ROI�� 115 11.3 Freezing an Image�� 115 11.4 Using Cine�� 116 11.4.1 Reviewing Cine �� 116 11.4.2 Cutting Cine �� 116 11.5 Annotations and Body marks�� 116 11.5.1 Annotating an Image�� 116 11.5.2 Body mark�� 117 11.5.3 Deleting Annotations and Body marks�� 117 11.6 ECG Module�� 118 11.6.1 ECG�� 118 11.6.2 PCG�� 119 11.6.3 Pulse Wave�� 120 11.7 Stress Echocardiography�� 120 11.7.1 Acquiring Echocardiograms�� 120 11.7.2 Making Comparative Analysis�� 121 11.7.3 Scoring for Wall Motion�� 122 11.8 Quantitative Analysis�� 122

12 Managing Images/Data��125 12.1 Storing an Image�� 125 12.1.1 Storing 2D Image�� 125 12.1.2 Storing 3D/4D Image�� 125 12.2 Storing an Sonogram Navigation Image�� 125 12.3 Viewing an Image�� 126 12.3.1 Viewing a Current Image�� 126 12.3.2 Retrieving an Image�� 127 12.4 Sharing Data�� 127

IV

Contents 12.5 Backing up Data�� 128 12.5.1 Backing up Data to a USB drive�� 128 12.5.2 Backing up Data to DVD�� 128 12.6 Importing Data to the System�� 128

13 Working with DICOM�� 131 13.1 Verifying Connectivity�� 131 13.2 DICOM Storage�� 131 13.2.1 Storing the Current Image�� 131 13.2.2 Storing Patient Data�� 131 13.3 DICOM Print�� 132 13.3.1 Printing the Current Image�� 132 13.3.2 Printing Patient Data�� 132 13.4 DICOM Worklist�� 132 13.5 MPPS�� 133 13.6 Storage Commitment�� 134 13.7 DICOM Queue�� 135 13.8 Query/Retrieve List�� 135

14 Probes and Biopsy�� 137 14.1 Probe�� 137 14.1.1 Available Probes�� 137 14.1.2 Probe Usage�� 138 14.1.3 Cleaning the Probe�� 139 14.1.4 Disinfecting and Sterilizing the Probe�� 140 14.1.5 Disinfecting and Sterilizing the Probe Cable�� 142 14.1.6 Storage and Transportation�� 143 14.2 Biopsy�� 143 14.2.1 Available Biopsy Brackets�� 144 14.2.2 Assembling the Biopsy Bracket�� 145 14.2.3 Preparing for a Biopsy�� 147 14.2.4 Verifying the Biopsy Bracket�� 147 14.2.5 Performing a Biopsy�� 148 14.2.6 Cleaning the Biopsy Bracket�� 149 14.2.7 Sterilizing the Biopsy Bracket�� 149 14.2.8 Storage�� 150

15 System Maintenance�� 151 15.1 Cleaning the System�� 151 15.2 Maintenance Checks�� 152 15.3 Troubleshooting�� 152 15.4 Replacing the Fuse�� 153 15.5 Equipment Disposal�� 153 15.6 Customer Service�� 153

Appendix A Specifications�� 154 Appendix B EMC Guidance and Manufacturer’s Declaration�� 155 B.1

Electromagnetic Emissions�� 155

B.2

Electromagnetic Immunity�� 156

V

Contents B.3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Equipment�� 158

Appendix C In Situ, Derated, and Water Value Intensities�� 159 Appendix D Recommended Coupling Gel, Cleaner and Disinfectant�� 160 D.1

Coupling Gel�� 160

D.2

Cleaner�� 161

D.3

Disinfectant�� 161

Appendix E Acoustic Output Data�� 162

VI

1

Safety

This chapter describes the important information for operating this ultrasound system. To ensure the safety of both operator and patient, please read the relevant details in this chapter carefully before using this system. You should be thoroughly familiar with the precautions provided in this manual. Otherwise, the manufacturer is not responsible for the effects on safety, reliability and performance of the system.

1.1

Intended Use The SonoScape system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. The ultrasound system also provides the measurement and calculation packages used for clinical diagnosis purposes. For details, please refer to the advanced user manual. Contraindication: The ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

! 1.2

Precautions must be considered in the use of any application. Otherwise, it may result in system damage or serious injury.

Safety Precautions Read and understand all precautions in this manual before attempting to use the system. Keep this manual with the system at all times. Review the procedures for operation and safety precautions periodically.

1.2.1

!

Electrical Safety ●● Only qualified physicians or sonographers can perform ultrasound scanning on human subjects for medical diagnostic reasons. ●● Any unauthorized personnel should not tamper with the main unit of the system. ●● Do not service or maintain the system while it is in use with a patient. ●● Do not position the system to make it difficult to disconnect it. ●● Do not use the system with flammable anaesthetics (category AP) or flammable anaesthetics with oxidants (category APG). ●● Do not use the system with other equipment such as an electric knife, high-frequency therapy equipment, or a defibrillator. Otherwise, electrical shock may occur. ●● Connect the protective earth conductor only before powering on the system. Disconnect the ground wire only after powering off the system. Otherwise, electrical shock may occur. ●● Connect the system to the other electrical equipment by using the potential-equalization lead wire before connecting the power plug of the system to an electrical outlet. ●● Do not place the multiple socket-outlet on the floor.

1

1 Safety ●● The video printer should be connected to the specific interface by using the cable provided by the manufacturer. Otherwise, electrical shock may occur. ●● Within the environment that is 1.8 meters (6 feet) around a patient, connect peripherals to the auxiliary power outlet which is capable of isolation protection; or, power the peripherals by the auxiliary output cable or the isolation transformer complied with EN/IEC 60601-1, or the power input of the same safety level. ●● Within the patient environment, when removing the covers or the connectors from the non-medical electrical equipment without tools during maintenance, calibration or ot her operations, do not touch the parts of the nonmedical electrical equipment and the patient simultaneously. ●● Use only the probes provided by the manufacturer. Otherwise, the system will not perform, and an accident such as a fire may result in the worst case. ●● Only the peripherals and accessories provided or recommended by the manufacturer can be used. Using other devices or accessories may degrade the system’s performance and even cause electrical shock. ●● Do not pour any fluid onto the system surfaces, as fluid seepage into the electrical circuitry may cause excessive electrical current leakage or system failure. If any water is spilled onto the system carelessly, stop using the system and contact the local distributor immediately. ●● The AC power plug for the system is a three-prong grounded plug and should never be adapted to any twoprong outlet or by using an adapter. Connect the AC power plug of the multiple socket-outlet to a hospital-grade power outlet. ●● If the system is transported to the operating environment with a great temperature change, leave it for approximately 4 hours before powering it on. Ensure that the temperature and humidity inside and around the system are equivalent before an operation. ●● Do not use the system around a strong electric field, a strong electromagnetic field, or the devices which generate radio waves, such as a radio, cellular telephones, or transceivers. Using the system in an improper environment may result in malfunction or damage. ●● Select the conformed multiple socket-outlet with protective grounding, and ensure that its maximum output power exceeds the requirement of the system. ●● The multiple socket-outlet can only be used to provide power to the recommended peripherals of the system. ●● Do not connect other devices to the multiple socket-outlet. Otherwise, the rated output power of the multiple socket-outlet may be exceeded, and it may result in failure. ●● Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN/IEC standards (for example, EN/IEC 60950 for data processing equipment and EN/IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standards EN/IEC 60601-1. ●● Do not use an endocavitary probe on the body surface of a patient. Otherwise, the electromagnetic compatibility of the probe may be degraded. ●● If the non-medical electrical equipment used with the system is supplied by a multiple socket-outlet with separating transformer, connect the AC power plug of the multiple socket-outlet to a hospital-grade power outlet. Consult a professional to ensure that the connection complies with the safety standards.

1.2.2

!

Mechanical Safety ●● To avoid possible personnel injury and system damage, move the system slowly and carefully. ●● During the movement, the system could cause injury if the casters roll over feet or into shins. Exercise extreme caution while moving the system for a long distance, and up or down the ramp. ●● Lock the foot brakes after arrival. ●● Do not place other objects on top of the control panel. Do not sit on the control panel or any other part of the system. ●● Disconnect the foot switch and the power cable before moving the system.

2

Basic User Manual

1 Safety ●● Do not knock or shake the system. ●● Ensure that the casters are intact and can rotate well before moving the system. ●● Always use the handle to move the system. ●● Ensure that the foot brakes are released and all cables are away from the casters before moving the system.

1.2.3

!

Accessories Caring ●● Disconnect the probe from the system after freezing an image or powering off the system. Otherwise, the system or the probe could be damaged. ●● Do not use the foot switch in the operating room. ●● Use the probe carefully. If any part of the transducer surface is scratched, stop using the probe immediately. Otherwise, electrical shock may occur. ●● After disinfecting the accessories, wash out chemicals or discharge gases thoroughly from the accessories. Residual chemicals or gases could result in damage to the accessories, and be harmful to human bodies. ●● Only trained physicians or sonographers under ultrasound guidance can handle the biopsy needle guides. During the operation, the operator must observe proper needle insertion sequencing with the needle guide to avoid undue discomforts, unnecessary risks or injuries to the patient. ●● Use the legally marketed probe sheath. Refer to package labeling to determine latex content. Natural rubber latex may cause anaphylactic reactions in some individuals. Avoid contact with items containing natural rubber latex. Refer to the FDA Medical Alert, March 29, 1991. ●● Use the legally marketed coupling gel in accordance with relevant local regulations. Read and understand all precautions in the relevant manual of the coupling gel before use. ●● Prepare, use, store and dispose the cleaner, disinfectant and sterilant according to the instructions provided by manufacturers. Do not disconnect the probe during the real-time scan. Otherwise, it may damage the probe and the system.

1.2.4

Biohazard Considerations ●● To minimize the risk of cross-contamination or infectious diseases when performing a biopsy, the operator should wear disposable gloves, protective clothing or protective goggles if it is needed. Follow the working regulations strictly in case the skin contacts the samples. ●● Some disinfectants or sterilants are acid or alkaline. Use them with caution, and prevent hands or clothing from coming into direct contact with them. Wash hands or eyes immediately in case of any contamination by disinfectants. ●● Dispose of cleaners, disinfectants or solutions in accordance with local standards or regulations.

1.3

!

Acoustic Power Principle ●● Perform ultrasound procedures prudently under the guidance of the ALARA (as low as reasonably achievable) principle. Only expose the patient to the lowest practical transmit power levels in the shortest possible period to achieve a satisfactory diagnosis. ●● Freeze the image at any time if you are not operating the system for a long period of time. ●● Do not scan the same part of an patient continuously or expose the patient to prolonged scanning. Doing so may harm the patient. ●● Do not expose the fetus to prolonged scanning in the Doppler mode. ●● Although the output power is automatically controlled for the selected applications, high TI values should be kept to a minimum or avoided in obstetric applications.

Basic User Manual

3

1 Safety ●● You should be familiar with the performances and operations of the system, observe the ultrasound output parameters on the screen at all times.

1.3.1

Biological Safety Diagnostic ultrasound is recognized as being safe, but the possibility of biological effects exists when using it in high exposure levels and long exposure times. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

1.3.2

ALARA It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that the total energy level is controlled below a low enough level at which bioeffects are not generated while diagnostic information is being accumulated. The total energy is controlled by output intensity and total radiation time. The output intensity necessary for examinations differs depending on the patient and the clinical case. Not all examinations can be performed with an extremely low level of acoustic energy. Controlling the acoustic level at an extremely low level leads to low-quality images or insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However, increasing the acoustic power more than necessary does not always contribute to an increase in quality of information required for diagnosis, rather increasing the risk of generating bioeffects. The operator must take responsibility for the safety of the patient and utilize the ultrasound deliberately. Deliberate use of the ultrasound means that output power of the ultrasound must be selected based on ALARA. Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound are available in a document from the AIUM (American Institute of Ultrasound in Medicine) titled “Medical Ultrasound Safety”.

1.3.3

Mechanical and Thermal Indices The display of the system consists of two parts: Thermal Index (TI) and Mechanical Index (MI).

■

MI/TI Explanation In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as the StoweReport, which reviewed available data on possible effects of ultrasound exposure. Another report “Bioeffects and Safety of Diagnostic Ultrasound” dated January28, 1993, provides more current information. ●● Mechanical Index (MI) Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with different types of tissue. The potential mechanical bioeffects varies with peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. There is no specific MI value that means that a mechanical effect is actually occurring. The MI should be used as a guide for implementing the ALARA principle. ●● Thermal Index (TI) The TI value informs the operator about the conditions that might lead to an increase in temperature on the surface of the body, within the body tissue, or at the point of focus of the ultrasound beam on bone. That is, the TI value informs the operator about the potential temperature rise in body tissue. It is an estimate of temperature increase in body tissue with specific properties. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, mode of operation and others. The TI value should be used as a guide for implementing the ALARA principle. Depending on the examination and type of tissue involved, TI could be one of three types: −− Soft Tissue Thermal Index (TIS) is used when imaging soft tissue only, it provides an estimate of potential temperature rise in soft tissue. −− Bone Thermal Index (TIB) is used when bone is near the focus of the image as in the third trimester, it provides an estimate of potential temperature rise in the bone or adjacent soft tissue.

4

Basic User Manual

1 Safety −− Cranial Bone Thermal Index (TIC) is used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature rise in the bone or adjacent soft tissue.

■

MI/TI Display TI and MI values are displayed in real time on the screen. The operator should observe these index values during examinations and ensure that exposure time and output values are maintained at the minimum amounts needed for effective diagnosis. The MI and TI precision is 0.1.

1.3.4

Transducer Surface Temperature Limits For probes intended for internal applications, e.g. the endocavitary probe or transesophageal probe, the surface temperature of the probe may change by adjusting system parameters. The maximum surface temperature of the endocavitary probes is 43°C. To protect the patient against the harm of excessive temperature, the probe stops working automatically when its temperature reaches the limit. The surface temperature of the probe is displayed on the screen.

1.3.5

PAT：37.0℃

Patient Temperature Threshold

TIP： < 28℃

Transducer Tip Temperature

Imaging Functions that Change Acoustic Output The qualified operator may use the system controls to limit the ultrasound output and to adjust the quality of the images. The operator should observe the acoustic output display for possible effects. There are three categories of system controls relative to output. They are controls that have direct effect on the output, controls that indirectly control output and controls that are receiver controls.

1.4

Safety Symbols The following table is provided for your identification of important symbols located in labels on the system. Symbol

Meaning Caution

Dangerous voltage

Pinch hazard

Risk of explosion if used in the presence of flammable anesthetics

This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC. Authorized representative in the European community Type BF Applied Part

Basic User Manual

5

1 Safety

Symbol

Meaning Main switch OFF Main switch ON On/Standby switch

Foot switch Connector

Protective earth (ground)

Equipotentiality

Alternating current Degree of IP protectionNon-ionizing electromagnetic radiation

Manufacturer

Date of manufacture

Follow instructions for use

Network Port

Control port of color video printer

USB Port Video Input Video Output Audio

Fragile

6

Basic User Manual

1 Safety

Symbol

Meaning Keep dry

No stacking

Keep this way upward

This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. Serial Number Heating

Rotate control panel left or right Rotate control panel up or down

General warning, caution, risk of danger. DO NOT push the system when the casters are locked. Beware of excessive stress exerted to the system. DO NOT sit on the system.

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7

This page is intentionally left blank.

2

System Overview

This ultrasound system adopts advanced ultrasonic Doppler technologies. To ensure the performance and availability of this ultrasound system, you should be thoroughly familiar with the operations of system components, the control panel, the key panel and the basic screen.

2.1

Standard System Configuration The standard system configuration mainly consists of the following items: ●● Main unit ●● Probes ●● Others: See the packing list in the packaging box.

2.2

Physical Specifications ●● Lifting range: 0-230mm ●● System dimensions: −− With a 18.5 inch monitor, approx. 751mm(W)×1335mm(H)×518mm(D) (The height is measured when the monitor and control panel are in their lowest positions.) −− With a 21.5 inch monitor, approx. 751mm(W)×1360mm(H)×526mm(D) (The height is measured when the monitor and control panel are in their lowest positions.) ●● System weight: approx. 86 kg

9

2 System Overview

2.3

System Components

1

2

16 17

3

25

15

4

14

5

24 13 12

6

18

23

7

22

11 10

8

21

19

9 20

Figure 2-1 Left and Right View of the System 1

Monitor

14 Handle

2

Touch Screen

15 Key Panel (optional)

3

Speaker

16 Control Panel

4

Coupling Gel Heater (optional)

17 Probe Holder

5

Probe Holder

18 Cable Hanger

6

Cable Hanger

19 Dust Filter

7

On/Standby Button

20 Power Supply Panel

8

Dust Filter

21 Peripheral Device Panel

9

Caster

22 Fans

10 Foot Switch Port

23 Cable Hanger

11 Probe Port

24 Document Basket

12 Front Panel

25 Handle

13 Probe Cable Hanger

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Basic User Manual

2 System Overview

2.3.1

Peripheral Device Panel 1

14

13

2

12

11

3

10

9

4

8

7

6

5

Figure 2-2 Peripheral Device Panel No.

Name

Description

1

HDMI port

Connect a video device to acquire HDMI signals.

2

VGA OUT port

Connect a video device to acquire VGA signals.

3

RGB OUT port

Connect a video device to acquire RGB signals.

4

DVI port

Connect a video device to acquire DVI signals.

5

PRINT port

Connect a video printer.

6

MIC IN port

Reserved function

7

AUDIO IN port

Reserved function

8

AUDIO OUT port

Connect an audio device.

9

S-VIDEO IN port

Reserved function

10

S-VIDEO OUT port

Connect a video device to acquire S-VIDEO signals.

11

VIDEO IN port

Reserved function

12

Net port

Connect to the DICOM server or network.

13

VIDEO OUT port

Connect a video device to acquire standard signals.

14

USB port

Connect USB devices.

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2 System Overview

2.3.2

Power Supply Panel

1

2

3

4

Figure 2-3 Power Supply Panel

2.3.3

No.

Name

Description

1

POWER switch

Power on or off the system.

2

Power input

Connect the power cable.

3

Voltage conversion switch

Convert the voltage.

4

Equipotentiality

Balance the protective earth potentials between the system and the other electrical equipment for equipotential connection.

Front Panel 1

2

8

3

7

4

5

6

Figure 2-4 Front Panel

12

No.

Name

Description

1

DVD drive

Backup data or images.

2

USB ports

Connect the USB drives.

3

Mains supply indicator

Indicate the mains supply status.

4

Battery charging indicator

Indicate the battery charging status.

5

Battery discharging indicator

Indicate the battery power status.

6

Pencil probe port

Connect the pencil probe.

7

ECG port

Connect the ECG cable.

Basic User Manual